Core Points - NKGen Biotech has received Fast Track designation from the U.S. FDA for its NK cell therapy, troculeucel, aimed at treating moderate Alzheimer's disease [2][3] - The Fast Track designation is designed to expedite the development and review process for therapies addressing serious health conditions and unmet medical needs [4] - NKGen is currently enrolling patients in a Phase 2a trial for troculeucel and anticipates sharing updated clinical data by the end of 2025 [3] Company Overview - NKGen Biotech is a clinical-stage biotechnology company focused on developing and commercializing innovative autologous and allogeneic natural killer cell therapeutics [6] - The company is headquartered in Santa Ana, California, and aims to address neurodegenerative disorders and various cancers with its therapies [6][5] Product Information - Troculeucel is an ex vivo expanded autologous NK cell immunotherapeutic drug candidate, with the International Nonproprietary Name (INN) SNK01 assigned by the WHO [5] - The therapy targets the moderate stage of Alzheimer's disease, which constitutes about 30% of all Alzheimer's cases, addressing a significant unmet need in the market [3]

Core Viewpoint - NKGen Biotech has been selected as the preferred stalking horse bidder for NKMax Co., Ltd. in its court-managed rehabilitation process, which is similar to Chapter 11 in the US, and this acquisition is expected to secure global IP rights for NKGen, allowing commercialization of troculeucel in various markets [2][3][4] Group 1: Acquisition Details - NKGen's proposal includes up to $18 million in committed funding from a third-party investor [2] - The acquisition process will involve a public offering, with NKGen having the final right of first refusal on any other qualified offers [2] - The final decision and rehabilitation plan approval by NKMax's creditors and the court is expected in February 2025, with closing anticipated thereafter [2] Group 2: Intellectual Property and Commercialization - NKMax currently holds master global rights to the intellectual property for troculeucel and other proprietary IP licensed to NKGen for markets outside Asia [3] - The acquisition is expected to consolidate global rights under NKGen, enhancing its ability to commercialize troculeucel for Alzheimer's and other neurodegenerative diseases in Japan and South Korea [3][4] - NKGen aims to begin commercialization in countries where autologous non-genetically modified cell therapy is legal, including Japan, Thailand, Malaysia, and Mexico [4] Group 3: Company Background - NKGen Biotech is a clinical-stage biotechnology company focused on developing innovative autologous and allogeneic natural killer cell therapeutics [8] - NKMax, founded in 2002, is also a clinical-stage biotechnology company specializing in immune cell therapies and has a GMP-certified manufacturing facility [6]

Core Insights - NKGen Biotech's troculeucel shows promise in reducing biomarkers associated with Alzheimer's Disease (AD), potentially delaying or preventing dementia onset in asymptomatic individuals [1][4][5] - Preliminary results from a Phase 1/2a trial indicate that troculeucel is safe and effective, with 100% of subjects showing stable or improved cognitive function after treatment [2][6] - The company presented findings at the 17th Clinical Trials on Alzheimer's Disease Annual Meeting, highlighting the potential of troculeucel as a treatment for moderate AD [3][8] Biomarker Analysis - Troculeucel reduces levels of GFAP, NfL, p-tau181, GDF-15, and LTBP2, which are detectable up to 10 years before dementia symptoms appear [1][4] - In a recent study, 70% of subjects showed improvement in p-Tau181, 60% in the AB42/40 ratio, and 30% in NF-L after treatment [7] - The analysis suggests that increased screening for these biomarkers in asymptomatic individuals could identify those at high risk for AD [5][7] Clinical Trial Results - In the Phase 1/2a trial, three subjects received the highest dose of 6 billion cells, with two showing clinical improvement from moderate to mild AD after three months [2][8] - The treatment was well-tolerated, with no adverse reactions reported, and 90% of evaluable subjects experienced stable or improved cognitive function [5][6] - The ongoing Phase 2a trial aims to confirm the efficacy of troculeucel in a larger, randomized cohort [6][8] Company Overview - NKGen Biotech is focused on developing innovative autologous and allogeneic natural killer cell therapeutics for neurodegenerative disorders and cancers [10][11] - Troculeucel, the company's lead product, is a patient-specific ex vivo expanded autologous NK cell immunotherapeutic drug candidate [10] - The World Health Organization has assigned the International Nonproprietary Name (INN) for troculeucel, marking a significant step towards commercialization [10]

Core Insights - NKGen Biotech Inc. is set to present findings from a Phase 1 dose escalation study and a preliminary report from a follow-up Phase 1/2a study of troculeucel for Alzheimer's disease at the 17th Annual Clinical Trials on Alzheimer's Disease Conference in Madrid from October 29 to November 1, 2024 [1] Presentation Details - The first presentation titled "Treatment of Moderate Alzheimer's Disease Subjects with Expanded Non-genetically Modified Natural Killer Cells (troculeucel; SNK01) with Enhanced Activity" will report Phase I results [2] - The second presentation titled "Use of Non-genetically Modified Natural Killer Cells (SNK01) With Enhanced Activity in Subjects with Active Alzheimer's Disease" will include further biomarker analysis [3] Publication Information - Full abstracts accepted as poster presentations will be published in the special CTAD edition of the Journal of Prevention of Alzheimer's Disease [4] Product Information - Troculeucel is a novel patient-specific ex vivo expanded autologous natural killer cell immunotherapeutic drug candidate, being developed for neurodegenerative disorders and various cancers [5] Company Overview - NKGen Biotech is a clinical-stage biotechnology company focused on innovative autologous and allogeneic natural killer cell therapeutics, headquartered in Santa Ana, California [6]

Financial Performance - The company reported net losses of $16.1 million for the three months ended June 30, 2024, and an accumulated deficit of $183.6 million as of the same date[176]. - The company has no products approved for sale and recognized no revenue during the three and six months ended June 30, 2024, and 2023[179]. - Net loss for the three months ended June 30, 2024, was $16.1 million, representing an increase of $8.2 million, or 105%, compared to a net loss of $7.8 million in the same period in 2023[191]. - Net loss for the six months ended June 30, 2024, was $21.5 million, an increase of $5.3 million, or 33%, compared to a net loss of $16.2 million in the same period in 2023[192]. - The company reported net cash used in operating activities of $10.0 million for the six months ended June 30, 2024, compared to $10.4 million for the same period in 2023, indicating a decrease of approximately 3.8%[238][239]. Research and Development - The company received IND clearance from the FDA for SNK01 in Alzheimer's disease on October 20, 2023, and began dosing participants in the clinical trial on December 28, 2023[172]. - In a Phase I clinical trial for SNK01, 30% of patients showed clinical improvement on the ADCOMS score compared to baseline, and 60% showed stable scores[173]. - The company plans to conduct a Phase 2 trial for SNK01 involving 30 patients with moderate Alzheimer's disease, following clearance from an Independent Review Board[174]. - Research and development expenses are expected to increase as the company continues to develop its product candidates and platform[181]. - Research and development expenses decreased by $1.0 million, or 24%, for the three months ended June 30, 2024, compared to the same period in 2023[193]. - Total research and development expenses for the six months ended June 30, 2024, were $15.1 million, an increase of $1.7 million, or 12%, compared to $13.4 million in the same period in 2023[192]. Expenses and Costs - General and administrative expenses increased by $1.8 million, or 71%, for the three months ended June 30, 2024, compared to the same period in 2023[190]. - Total expenses for the three months ended June 30, 2024, were $7.5 million, an increase of $0.8 million, or 13%, compared to $6.6 million in the same period in 2023[190]. - Interest expense for the three months ended June 30, 2024, was $0.6 million, an increase of $0.9 million, or 944%, compared to $0.06 million in the same period in 2023[191]. - General and administrative expenses increased by $3.0 million, or 52%, for the six months ended June 30, 2024, primarily due to a $2.6 million increase in professional fees[202]. - The company incurred significant transaction costs related to the Business Combination and issued several financial instruments, including Senior Convertible Notes[171]. Funding and Capital - The company expressed substantial doubt about its ability to continue as a going concern without securing additional funding[178]. - The company expects to finance its cash needs through a combination of equity and debt financings, which may dilute existing stockholders' ownership[213]. - The company raised total proceeds of $10.2 million from the issuance of 10,209,994 PIPE warrants at a purchase price of $1.00 per warrant[231]. - The company raised $1.5 million from private placement agreements during the six months ended June 30, 2024[228]. - The company issued additional debts of $3.2 million in July and August 2024, including $3.0 million in 2024 Convertible Notes[215]. Debt and Liabilities - As of June 30, 2024, the company had cash and cash equivalents of $0.1 million and a working capital deficit of approximately $50.2 million[214]. - The company had outstanding debts of $35.8 million as of June 30, 2024, which included a revolving line of credit with East West Bank[215]. - The company incurred approximately $15.1 million in accounts payable and accrued expenses related to transaction expenses from the Business Combination as of June 30, 2024[215]. - The company experienced an increase in accounts payable and accrued expenses, contributing to the net cash used in operating activities[238]. Fair Value Measurements - The company determined that the Public Warrants and Deferred Founder Shares are classified as equity instruments, while various convertible notes and warrants, including Senior Convertible Notes and PIPE Warrants, are classified as liabilities[257]. - The fair value of liability-classified instruments, such as Private Warrants and Working Capital Warrants, is measured using Level 3 inputs and accounting estimates, which can significantly affect reported financial positions[262]. - The estimated fair value of the liability classified warrants was determined using a Black-Scholes model, incorporating assumptions related to expected stock-price volatility and risk-free interest rates[263]. - The fair value of the 2024 Convertible Notes will be measured using a probability weighted scenario model starting April 1, 2024, reflecting changes in entity-specific assumptions and the diversity of expected behaviors[266]. Company Classification - The company qualifies as an emerging growth company and may remain so for up to five years, allowing it to rely on certain exemptions from public company reporting requirements[271]. - The company qualifies as a "smaller reporting company" with a market value of common stock held by non-affiliates plus proposed gross proceeds from the Business Combination being less than $700.0 million[273]. - The company's annual revenue is less than $100.0 million during the most recently completed fiscal year[273]. - Smaller reporting companies have reduced disclosure obligations regarding executive compensation[273].

Two of the first three patients in the Phase 1 cohort of the Phase 1/2a clinical trial, treated at the highest dose of 6 billion cells per treatment, were found to have improved CDR-SB cognitive scores, resulting in a clinical upgrade from moderate AD to mild AD after only three months on therapy. First patient dosed in the Phase 2 cohort of the trial, continuing at the highest dose of 6 billion cells per treatment. With the advancement to Phase 2 of the trial, SNK01 will now be referred to by its INN name, ...

SNK01, a cryopreserved autologous non-genetically modified NK cell product, is able to effectively reduce αsynuclein (α-syn) protein levels in the cerebral spinal fluid (CSF) of Alzheimer's patients; an important finding since increased α-syn has been correlated with worse cognitive performance and is not a target for any currently approved Alzheimer's treatments SANTA ANA, Calif., July 30, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (NASDAQ:NKGN) ("NKGen" or the "Company"), a clinical-stage biotechnology ...

SNK01, a cryopreserved autologous non-genetically modified NK cell product, is able to effectively reduce αsynuclein (α-syn) protein levels in the cerebral spinal fluid (CSF) of Alzheimer's patients; an important finding since increased α-syn has been correlated with worse cognitive performance and is not a target for any currently approved Alzheimer's treatments SNK01 treatment appears to stabilize or improve cognitive function and reduce α-synuclein levels in CSF in addition to improving previously report ...

NKGen will present data on SNK01's ability to reduce α-synuclein in Alzheimer's patients, which is significant given that α-synuclein has been shown to correlate with worse cognitive function in Alzheimer's disease. Presentation details are as follows: More information about AAIC 2024 can be found at: https://aaic.alz.org/. About NKGen Biotech Statements contained in this press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act and Section 21E of the Sec ...

More information about AAIC 2024 can be found at: https://aaic.alz.org/. A copy of the poster will be available on the Scientific Publications page of the Company's website at https://nkgenbiotech.com/ once the poster presentation has concluded. Previously disclosed Phase 1 data on the positive effects of SNK01 on amyloid, tau, and neuroinflammation biomarkers in Alzheimer's patients, which may not be included in this poster presentation, can also be found on the Scientific Publications webpage. About NKGen ...